9.1.20 - The ScriptDrop Team Taking the Pulse: FAQs about the COVID-19 Vaccine

There’s a light at the end of the pandemic tunnel, and it’s a COVID-19 vaccine. While it will not be a magical solution to our global crisis, it will be the first real line of defense against the novel coronavirus. Some research labs and manufacturers are working on vaccines that can do double-duty to treat the coronavirus, too. 

But if you’re like us at ScriptDrop, you’re feeling overwhelmed with COVID-19 news. What do you need to know about the vaccine? Where can you find more information? Read on for the basics and follow the links for more.   

First: what is Operation Warp Speed?

Generally, vaccines take many years to create, test, and produce. To speed up the process, the U.S. government developed Operation Warp Speed (OWS), a project whose goal is to deliver 300 million doses of a safe and effective coronavirus vaccine by January 2021. 

OWS is meant to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics in several ways. First of all, the government is investing between eight and ten billion dollars in the project. Second, they have worked to identify the most promising vaccine candidates and have allowed drug testing to proceed more quickly than usual. 

Which manufacturers are developing vaccines?

To put it simply: a lot of them. The World Health Organization keeps a running list that tracks the manufacturers and which stage of testing they are in. The New York Times also has a list with the frontrunners categorized by type of vaccine.

We combed these resources to compile a quick list of the manufacturers you’re most likely to see in the news: 

What’s the deal with the Russian vaccine?

The vaccine from Russia’s Gamaleya Research Institute did not pass through phase 3 clinical trials before being approved for use. There’s a chance that it will produce an acceptable level of immunity and won’t cause any harm. But there is also a chance that it won’t work and could cause severe side effects

If either of these were to happen, Gamaleya’s vaccine could undermine global inoculation efforts by making COVID-19 vaccines seem less trustworthy.

What do the testing “phases” mean?

Normally, vaccines must pass through phases of testing before they are approved for general use. 

  • Preclinical testing: The vaccine is tested on cells, then animals. If the vaccine produces an immune response, then it can proceed. 
  • Phase 1 safety trials: Moderate doses of the vaccine are tested on a small sample of healthy adults to determine its safety.
  • Phase 2 expanded trials: The vaccine is tested on hundreds of people in different demographics (e.g. children, elderly, etc.) to further examine its safety and efficacy. Different doses may be tried. 
  • Phase 3 efficacy trials: The vaccine is given to thousands of volunteers while others are given a placebo. Volunteers are tracked to see whether they become infected or are protected by the vaccine, and whether they develop side effects. 

Many countries are allowing some of these trials to be combined to speed up the testing process. Most commonly, phases 1 and 2 are combined, with the first human tests performed on hundreds of people instead of just a few.  

Once phase 3 trials are complete, regulators will review the results and determine whether the vaccine is approved. However, the COVID-19 vaccines might receive emergency use authorizations that will allow them to be distributed before they’re formally approved. 

What’s the difference between the vaccine types?

The main types of vaccines include: 

  • Nucleic acid-based: uses part of the virus’s genetic material – usually mRNA – to provoke an immune response. This technology has not been used before in human vaccines. 
  • Protein-based: uses the coronavirus spike protein (the part of the virus that binds to human cells) to provoke immune response.  
  • Viral vector-based: uses a different, weakened or inactivated virus to insert coronavirus genes into cells. This provokes immune response without letting the virus replicate. 
  • Virus-based: uses a weakened or inactivated virus to provoke an immune response. 

Most of these vaccines will induce antibody production against the spike protein on the surface of the coronavirus. Since the virus uses these spike proteins to attack cells, antibodies that block the proteins will essentially neutralize the virus. 

Many of these vaccines are being tested in one- and two-shot doses. In the case of Johnson & Johnson’s vaccine, a single shot provided immunity in animal subjects, but the second shot greatly boosted antibody response. 

When will a vaccine be widely available?

It’s not clear when the vaccine will be available. While Operation Warp Speed has January 2021 as its target date, officials like Dr. Fauci are estimating 12 to 18 months, making August 2021 a more likely date. However, some vaccines could potentially be approved for emergency use two months from now. 

Second, the vaccine won’t be widely available due to the sheer volume of people who will need it. Governments will need to develop allocation strategies to decide who should receive it first. Even then, there may not be enough doses for everyone in high-priority groups. The CDC expects that when a vaccine becomes available there will be 10 million to 20 million doses at first. 

Third, producing and distributing the vaccine itself will require new manufacturing facilities and immense resources. New factories may need to be built. The supply chain will need to be carefully thought out to ensure the vaccine stays cold during transportation. Even bottles could present a bottleneck: a specific, nonreactive glass is required for vaccine packaging, and not many companies produce it. 

Finally, even if it is widely available, remember that a vaccine could be approved via an emergency use authorization. In that case, the vaccine may not have been tested adequately on all patient groups, such as children, pregnant or breastfeeding people, or people with compromised immune systems. Some manufacturers still need to increase the number of Black, Latinx, and Indigenous volunteers in their studies, as well. 

When it does become available, where will I go to get it?

Hopefully, your local pharmacist will be able to administer the vaccine. That’s a sure thing in New York: Governor Cuomo signed legislation that will allow pharmacists to administer the vaccine. Pharmacy organizations like the American Pharmacists Association, the National Community Pharmacists Association, and the National Alliance of State Pharmacy Associations have since urged all other state governors to follow suit. 

What can I do in the meantime?

Keep following pandemic protocol. Continue to wear a mask. Avoid high-risk, crowded situations. Wash your hands frequently and disinfect surfaces and objects often. Keep taking your maintenance medication. If you need your prescription and are ill or want to avoid potentially contagious situations, try ScriptDrop home delivery

But also get a flu shot. The flu season usually starts in October in North America, and it’s especially important to be prepared this year. Not only is the flu dangerous in its own right, but having the flu puts you at much greater risk for COVID-19. 

Takeaways

Experts say that 70 to 80% of the American population will need to get the COVID-19 vaccine before we can develop herd immunity. Clearly we will need to wait awhile before we can walk into our local pharmacy and get the shot, but when that time comes, we all need to make the effort. Some patients may not be able to get the vaccine. They will depend on the rest of us to develop immunity and stop the spread of the virus. 

But the vaccine won’t “cure” COVID-19. Don’t expect to get the injection, rip off your mask, and go crowd-surfing at a concert. We will still need to remain cautious and continue practicing good hygiene. We can’t stop fighting yet.